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Abbvie, Inc. (ABBV) Tops Q2 EPS by 6c; Guides Q3 EPS to Strong Side

July 25, 2014 7:47 AM EDT

(Updated - July 25, 2014 7:50 AM EDT)

Abbvie, Inc. (NYSE: ABBV) reported Q2 EPS of $0.82, $0.06 better than the analyst estimate of $0.76. Revenue for the quarter came in at $4.93 billion versus the consensus estimate of $4.7 billion.

"This was another very strong quarter for AbbVie, as we delivered sales and earnings per share above our original guidance and announced plans to merge with Shire, a strategic action that will further enhance our long-term growth prospects," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "Last month, we raised our 2014 earnings-per-share guidance, reflecting strong underlying business performance. We continue to expect positive trends for the second half of the year, as well as additional progress from our pipeline, including the expected U.S. approval of our interferon-free HCV combination."

Key Events from the Second Quarter

  • AbbVie announced it reached an agreement with Shire's Board of Directors for a recommended transaction to combine the two companies. The proposed combination is strategically compelling for both companies and will create a larger and more diversified biopharmaceutical company with multiple leading franchises. The new company will also have significant financial capacity for future acquisitions, investment and enhanced shareholder distributions and value creation.
  • AbbVie announced the initiation of a Phase 3 clinical trial evaluating the safety and efficacy of its investigational compound, veliparib (ABT-888), when added to carboplatin and paclitaxel, two chemotherapeutic medicines, in patients with human epidermal growth factor receptor 2-(HER2) negative metastatic or locally-advanced breast cancer, containing BRCA1 and/or BRCA2 gene mutations. The trial will recruit approximately 270 patients. The primary efficacy outcome is progression-free survival. The secondary pre-specified outcome measures include overall survival, clinical benefit rate, objective response rate and duration of response. The start of this trial followed initiation of Phase 3 clinical work in two other settings: non-small cell lung cancer and neoadjuvant treatment of triple negative breast cancer.
  • Biogen Idec and AbbVie announced positive top-line results from the Phase 3 DECIDE trial, designed to evaluate the superiority of once-monthly, subcutaneous daclizumab high-yield process (DAC HYP) when compared to intramuscular interferon beta-1a (IFN β-1a), as a potential treatment for relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis. Results showed that DAC HYP was superior on the study's primary endpoint, demonstrating a statistically significant 45 percent reduction in annualized relapse rate (ARR) compared to IFN β-1a (p<0.0001).
  • AbbVie presented interim results from a Phase 1b clinical trial of ABT-199/GDC-0199, an investigational B-cell lymphoma 2 (BCL-2) selective inhibitor, in combination with rituximab. Results showed an overall response rate of 84 percent, in patients with relapsed/refractory chronic lymphocytic leukemia (CLL). These results were presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO). The combination of ABT-199/GDC-0199 and rituximab is being investigated in an ongoing Phase 3 clinical trial for the treatment of relapsed/refractory CLL.
  • AbbVie presented updated data from another Phase 1 study of ABT-199/GDC-0199 as a monotherapy including results from the trial arms investigating the compound as a treatment for patients with relapsed/refractory CLL and a variety of subtypes of non-Hodgkin's lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL). ABT-199/GDC-0199 as a monotherapy in patients with relapsed/refractory CLL harboring the 17p deletion is under investigation in an ongoing Phase 2 clinical trial.
  • Also at ASCO, AbbVie released preliminary results from an ongoing Phase 1 study of ABT-414, an anti-epidermal growth factor receptor (EGFR) monoclonal antibody drug conjugate, in combination with temozolomide, which showed four objective responses, including one complete response, in patients with recurrent or unresectable glioblastoma multiforme. The trial was designed to evaluate the toxicities, pharmacokinetics and recommended Phase 2 dose of ABT-414 when administered every other week in combination with temozolomide in patients with recurrent or unresectable glioblastoma. Other important assessments included adverse events, pharmacokinetic parameters, objective response and tumor tissue epidermal growth factor receptor biomarkers.
  • The New Drug Application for AbbVie's investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 hepatitis C virus (HCV) infection was accepted by the U.S. Food and Drug Administration (FDA) and granted priority review. Additionally, the Marketing Authorization Applications for AbbVie's HCV regimen were validated and are under accelerated assessment by the European Medicines Agency (EMA).
  • AbbVie and Bristol-Myers Squibb announced that the FDA has granted elotuzumab, an investigational humanized monoclonal antibody, Breakthrough Therapy Designation for use in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in patients who have received one or more prior therapies. Phase 3 studies are ongoing and expected to complete in 2015.
  • On June 19, the AbbVie board of directors declared a quarterly cash dividend of $0.42 per share, payable Aug. 15, 2014 to stockholders of record at the close of business on July 15, 2014.

Abbvie, Inc. reaffirmed FY2014 guidance.

The company sees Q2 EPS of $0.77 to $0.79, with consensus views at $0.77.

For earnings history and earnings-related data on Abbvie, Inc. (ABBV) click here.



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